Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp

Study Overview

• Status: Recruiting
• Conditions: Metabolic Disease
• Intervention / Treatment: Diagnostic test: Hyperglycemic Clamp; Drug: Kisspeptin-10; Drug: Placebo

Detailed Description

Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.

Delivery of Interventions:

Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.

During the inpatient study, the subjects will

Undergo a 16-hour kisspeptin infusion Undergo a hyperglycemic clamp

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Margaret Lippincott; Phone Number: 617-726-8434; Email: MGHKisspeptinResearch@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Margaret Lippincott

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

• over the age of 17
• normal pubertal development
• regular menstrual cycles
• stable weight for previous three months
• normal body mass index
• blood pressure systolic BP < 140 mm Hg, diastolic < 90 mm Hg
• normal hemoglobin
• hemoglobin A1C < 6.5%
• BUN, creatinine not elevated
• AST, ALT < 3x upper limit of normal
• negative serum pregnancy test

Exclusion Criteria:

• active illicit drug use,
• history of a medication reaction requiring emergency medical care,
• difficulty with blood draws.
• history of hypertension, diabetes, heart disease, high cholesterol, cancer, or clotting disorders.
• history of chronic disease that has required hospitalization
• recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug) unless it is birth control
• history of diabetes in a first degree relative
• hyperlipidemia by fasting lipid panel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Kisspeptin; Intravenous administration of kisspeptin 112-121 x 16 hours	Diagnostic test: Hyperglycemic Clamp; Administration of a hyperglycemic clamp; Drug: Kisspeptin-10; Administration of kisspeptin-10 * 16 hr
PLACEBO_COMPARATOR: Placebo; Intravenous administration of placebo x 16 hours	Diagnostic test: Hyperglycemic Clamp; Administration of a hyperglycemic clamp; Drug: Placebo; Administration of placebo *16 hr

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Phase Insulin Secretion	Average Change in First Phase Insulin Secretion Between Kisspeptin and Placebo Arms	10 minutes
Second Phase Insulin Secretion	Average Change in Second Phase Insulin Secretion Between Kisspeptin and Placebo Arms	2 hours

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Margaret Lippincott, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2022
• Primary Completion (ANTICIPATED): August 1, 2024
• Study Completion (ANTICIPATED): August 1, 2024

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (ACTUAL): July 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: 267335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No